Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K123008 |
Device Name |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN |
Applicant |
BIONIME CORPORATION |
55 NORTHERN BLVD. SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
JIGAR SHAH |
Correspondent |
BIONIME CORPORATION |
55 NORTHERN BLVD. SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
JIGAR SHAH |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/27/2012 |
Decision Date | 01/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|